Intraparenchymal Salivary Gland Corticosteroid Injection to Prevent Radiation-Induced Xerostomia

University of California, Davis10 enrolled

Overview

This study evaluates the feasibility and safety of ultrasound-guided intraglandular dexamethasone (corticosteroid) injections into the salivary glands of patients undergoing radiation therapy for head and neck cancer. Primarily, to determine among patients undergoing radiation therapy (RT) as primary with or without chemotherapy for head and neck cancer, the feasibility of intraglandular corticosteroid injections to the salivary glands as measured by missed or delayed days of radiation therapy due to the planned intervention. Secondarily, to determine safety of intraglandular injections to the salivary glands as measured by the incidence of adverse events. Exploratory endpoints will also be tracked to determine, if among the same population, intraglandular corticosteroid injections are efficacious in minimizing the deleterious effects of radiation treatment to the salivary glands as measured by salivary flow rates and patient reported outcomes.

This project will be divided into multiple phases - for this first phase, investigators plan to assess the safety and feasibility of the planned intervention. Using the introductory and background principles established above, investigators have planned the following intervention based off of available published data: serial intraglandular dexamethasone injections to salivary gland(s) affected by planned radiation treatment for non-salivary head and neck cancer. Ultrasound-guided technique will then be used to inject 1 cc of 4mg/mL of dexamethasone into each involved gland (up to 4 total glands) for the first five patients enrolled. The last five patients enrolled will have 1cc of 10mg/mL of dexamethasone injected into each involved gland (up to 4 total glands). Injections are administered at two time points: within 3 days of initiation of radiation therapy and within 1-3 days of starting the 3rd week of radiation therapy. The ultimate aim of this study is to provide enrolled patients prolonged avoidance of radiation-induced salivary damage by minimizing the inflammatory-mediated destruction of salivary gland tissue, as well as decreasing the incidence of post-treatment xerostomia and its deleterious effect on oral and dental hygiene, nutrition, voice, and overall quality of life.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

Interventions

Dexamethasone 4mg/mLDRUG

The 4 mg/mL injection strength may be used for intralesional and soft tissue administration. Doses range from 0.2 mg to 4 mg injected as a single dose at the appropriate site. 1 cc injected per gland via ultrasound-guided intraparenchymal technique into each involved salivary gland (up to 4 glands), via 2-3 injection sites that have been established to produce clinically sufficient distribution of injected solution.

Dexamethasone 10mg/mLDRUG

1 cc of 10mg/mL dexamethasone sodium phosphate injection solution injected per gland via ultrasound-guided intraparenchymal technique into each involved salivary gland (up to 4 glands), via 2-3 injection sites per gland.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients between the ages of 18-80 with recent primary diagnosis of Oropharyngeal, Nasopharyngeal, Hypopharyngeal or Laryngeal Squamous Cell Carcinoma * Radiation therapy as primary with or without chemotherapy * Mean dose greater than 20 Gy to 2 or more salivary glands based on dose volume histogram analysis in the radiation treatment planning software Exclusion Criteria: * Patients less than 18 years of age * Patients greater than 80 years of age * Patients undergoing any surgical therapies for head and neck cancer * Tumor involvement of salivary gland * History of salivary gland removal * History of prior head and neck radiation therapy * History of the following xerostomia-inducing autoimmune diseases: Sjogren's, Lupus, IGG4, and Rheumatoid Arthritis * History of lymphoma * History of chronic steroid use (greater than 3 months) within the past year * History of recent steroid use (in the 7 days prior to enrollment in the study) * History of radioactive iodine * History of adverse reactions to steroids * History of recurrent sialadenitis, sialoliths, or sialocele * History of Mumps * Chronic adrenal insufficiency * Malignant tumor or enlarged lymph nodes interfering with pathway for ultrasound-guided injections * Vulnerable populations: prisoners, adult patients unable to consent, pregnant women

Outcomes

Primary Outcomes

Number of Missed or Delayed Days of Radiation Therapy Due to Steroid Injection

Primary endpoint: Missed or delayed days of RT due to steroid injection. Count of radiation therapy treatment days that were missed or delayed as a direct result of the intraparenchymal dexamethasone injection procedure. To be assessed at every patient encounter.

Time frame: From first steroid injection through completion of radiation therapy, up to 6 weeks

Secondary Outcomes

Number of Participants Experiencing Adverse Events

Safety and feasibility at 3 months following investigational treatment. To be assessed at every patient encounter. Incidence of adverse events including, but not limited to: injection-site pain reported longer than 24 hours post-procedure, seroma, hematoma, missed injections, sialadenitis.

Time frame: From first steroid injection up to 12 weeks (3 months post-treatment)

Patient Tolerance of Injection Procedure

Assessment of patient tolerance during and after each ultrasound-guided intraparenchymal dexamethasone injection procedure.

Time frame: At each injection visit: Day 0 (pre-chemo/radiation) and Week 3 of radiation therapy

Ability to Inject 1cc of Dexamethasone Into Multiple Salivary Glands

Feasibility assessment of the ability to successfully inject 1cc of dexamethasone solution into multiple salivary glands (up to 4) as planned per protocol.